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NOT YET RECRUITING

NCT07894081

Evaluation of Gixam's Repeatability and Reproducibility Predicting the Presence of Advanced and Non-Advanced Colorectal Neoplasia

Sponsor: Jubaan Ltd.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if the Gixam tongue-imaging test gives the same result each time it is done, in adults aged 45 to 84 who are at average risk for colorectal cancer and are scheduled for a screening colonoscopy. The main questions it aims to answer are: * Does Gixam give the same result when the test is repeated on the same day, with the same device and the same staff member (repeatability)? * Does Gixam give the same result when the test is done on different days, with different devices and different staff members (reproducibility)? Participants will: * Answer questions about their health, medicines, diet, alcohol and tobacco use, and oral care habits * Have the Gixam tongue test 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14 * On Days 7 and 14, report when they last ate, drank or smoked, and whether they brushed, scraped their tongue or used mouthwash * Then join the main Gixam study (CL-1009) for a FIT stool test and their planned colonoscopy

Key Details

Gender

All

Age Range

45 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-11-02

Completion Date

2027-03-31

Last Updated

2026-10-26

Healthy Volunteers

Conditions

CRC Screening

Interventions

DEVICE

Gixam System

Repeated Gixam tests, 6 times over 2 weeks: 4 times on Day 1, once on Day 7 and once on Day 14

Inclusion Criteria: 1. Participants aged ≥45 - ≤84 years. 2. Able to provide a signed informed consent. 3. Considered by a physician or healthcare provider as being of 'average risk' for CRC. 4. Scheduled for a screening colonoscopy at investigation site. Exclusion Criteria: 1. Undergoing colonoscopy for investigation of symptoms. 2. Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention. 3. Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months. 4. Positive Cologuard, Sheild, ColoSense or Epi proColon test within the preceding three (3) years. 5. History of colorectal cancer. 6. Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age. 7. Participant has a diagnosis or medical / family history of any of the following conditions, including: * Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome) * Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome") * Other hereditary cancer syndromes including but not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis. 8. Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease. 9. Participants with a disability to extend their tongue. 10. Participants with tongue tremor. 11. Participants with tongue piercing. 12. Participants that had a dental visit in the 7 days prior to the Gixam test. 13. Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test. 14. Participants that have taken probiotics in the 14 days prior to the Gixam test. 15. Participant is pregnant. 16. Participant has any condition that in the opinion of the Investigator should preclude participation in the study.

Locations (1)

Orlando Gastroenterology, PA

Orlando, Florida, United States